[Federal Register Volume 73, Number 115 (Friday, June 13, 2008)]
[Rules and Regulations]
[Page 33692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-13354]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Ivermectin, Fenbendazole, and
Praziquantel Tablets
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of an original new animal drug
application (NADA) filed by Intervet, Inc. The NADA provides for the
veterinary prescription use of chewable tablets containing ivermectin,
fenbendazole, and praziquantel for the treatment and control of various
internal parasites and for the prevention of canine heartworm disease
in adult dogs.
DATES: This rule is effective June 13, 2008.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: Intervet, Inc., P.O. Box 318, 29160 Intervet
Lane, Millsboro, DE 19966, filed NADA 141-286 that provides for the
veterinary prescription use of PANACUR Plus (ivermectin, fenbendazole,
and praziquantel) Soft Chews for the treatment and control of various
internal parasites and for the prevention of canine heartworm disease
in adult dogs. The NADA is approved as of May 9, 2008, and the
regulations are amended in 21 CFR part 520 by adding Sec. 520.1200 to
reflect the approval.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for
3 years of marketing exclusivity beginning on the date of approval.
The agency has determined under 21 CFR 25.33(d)(1) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects in 21 CFR Part 520
Animal drugs.
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Therefore, under the Federal Food, Drug, and Cosmetic Act and under the
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
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1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
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2. Add Sec. 520.1200 to read as follows:
Sec. 520.1200 Ivermectin, fenbendazole, and praziquantel tablets.
(a) Specifications. Each chewable tablet contains either:
(1) 68 micrograms ([micro]g) ivermectin, 1.134 grams fenbendazole,
and 57 milligrams (mg) praziquantel; or
(2) 27 [micro]g ivermectin, 454 mg fenbendazole, and 23 mg
praziquantel.
(b) Sponsor. See No. 057926 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer tablets to
provide 6 [micro]g per kilogram (/kg) ivermectin, 100 mg/kg
fenbendazole, and 5 mg/kg praziquantel.
(2) Indications for use. For the treatment and control of adult
Toxocara canis (roundworm), Ancylostoma caninum (hookworm), Trichuris
vulpis (whipworm), and Dipylidium caninum (tapeworm), and for the
prevention of heartworm disease caused by Dirofilaria immitis in adult
dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Dated: June 4, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-13354 Filed 6-12-08; 8:45 am]
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